Overview

This trial is active, not recruiting.

Condition hiv infection
Treatments adherence reinforcement, antiretroviral therapy darunavir/r + raltegravir + 2 nrtis (as chosen by the investigators)
Phase phase 2
Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Start date March 2013
End date August 2016
Trial size 201 participants
Trial identifier NCT02025868, ANRS 12269 THILAO

Summary

Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire, Mali and Senegal, West Africa.

HIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA >1000 copies/ml) will be recruited and followed in two phases:

- First, a 12-week intentive adherence reinforcement phase, during which patients will continue 2nd-line ART, be seen repeatidly for counseling and educational training on adherence, and be offered the possibility of phone, SMS and home visit contacts with social workers;

- Second, a 48-week phase, during which:

- Patients successfully resuppressed at the end of the first phase will continue 2nd-line ART and adherence reinforcement;

- Patients with persitent virologic failure will switch to a darunavir/r + raltegravir-based 3rd-line ART.

Genotype resistance tests will be performed retrospectively on frozen samples. The main outcome will be the percentage of patients with plasma HIV-1 viral RNA <50 copies/ml at 64 weeks.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
adherence reinforcement
Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers.
antiretroviral therapy darunavir/r + raltegravir + 2 nrtis (as chosen by the investigators)
Second-line ART regimen : ongoing regimen at the time of inclusion will be continued. Third-line ART regimen : Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)

Primary Outcomes

Measure
Virologic efficacy of the adherence reinforcement intervention
time frame: Week 12
Persistent virologic efficacy of the adherence reinforcement intervention
time frame: Week 64
Virologic efficacy of 3rd-line ART
time frame: Week 64

Secondary Outcomes

Measure
Immunological efficacy of the adherence reinforcement intervention
time frame: Week 12
Immunological efficacy of 3rd-line ART
time frame: Week 64
Tolerance of 3rd-line ART drugs
time frame: Week 64
Adherence to 3rd-line ART
time frame: Week 64
Resistance to 1st and 2nd-line antiretroviral drugs
time frame: Week 12
Resistance to 1st, 2nd and 3rd-line antiretroviral drugs
time frame: Week 64
Plasma antiretroviral drugs concentration
time frame: Week 12
Plasma antiretroviral drugs concentration
time frame: Week 64

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: - Age >18 years - Documented HIV-1 infection - History of failing a NNRTI-based 1st-line ART - Current PI-based 2nd-line ART >6 months - Plasma HIV-1 RNA >1000 copies/ml - Signed informed consent Exclusion Criteria: - HIV-2 infection - Any Severe clinical event under exploration - History of treatment including darunavir or raltegravir.

Additional Information

Official title Systematic "Adherence Intervention" Phase Before Switching to 3rd-line ART in Patients With 2nd-line ART Virologic Failure in Sub-Saharan Africa : a Phase 2b Non-randomized Study.
Principal investigator Serge P. Eholie, MD, MSc, Pr
Description Main objective To estimate, in sub-Saharan African HIV-1 infected adults who failed a NNRTI-base first-line ART and then a PI-based second-line ART: 1. The efficacy (and associated factors) at 12 weeks of an intensive 3-months adherence reinfrocement phase; 2. In patients who successfully resuppress at 12 weeks: The percentage of patients still with continuing succesfull virologic supression on 2nd-line ART at 64 weeks (and factors associated to success) ; 3. In patients with persistent failure at 12 weeks : The efficacy (and associated factors) at 64 weeks of a darunavir/r + raltegravir-based 3rd-line regimen. Number of participants : 200 Main outcome : - At 12 weeks : Proportion of patients with a plasma HIV-1 RNA <400 copies/ml and/or with a decrease in plasma HIV-1 RNA >2 log10 copies/ml between inclusion and 12 weeks; - At 64 weeks : proportion of patients with a plasma HIV-1 RNA <50 copies/ml. Inclusion criteria: - Age >18 years - Documented HIV-1 infection. - History of failing a NNRTI-based 1st-line ART - Current PI-based 2nd-line ART >6 months - Plasma HIV-1 RNA >1000 copies/ml - Signed informed consent
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).